1. The Field of the Invention
The present invention relates to a device for treating deformational plagiocephaly. More particularly, the present invention relates to a device and method for correcting cranial deformation in a young child through minimally invasive means.
2. State of the Art
Over the last two decades, there has been a growing consensus among medical professionals that it is best to place an infant on his/her back while resting or sleeping. Some doctors and researchers have suggested that laying a child on his/her face increases the risk of Sudden Infant Death Syndrome (SIDS).
Because of this, it is much more common for an infant to be laid on his/her back for a substantial amount of time. For example, a child is placed on his/her back to sleep, as well as to entertain himself/herself while parents are otherwise occupied. Thus, an infant may spend as much as 20 plus hours per day laying on his/her back.
Because very young infants have relatively weak neck muscles and proportionately large heads, most young infants do not have the strength to move their heads from side to side. Thus, a young infant's head may remain tilted to one side or the other while the infant is lying on their back. At the same time, the bones in the infant's head are relatively soft and malleable. Thus, over a prolonged period of time, the weight of a child's head can gradually cause a deformation in the back of the skull called deformational plagiocephaly (i.e. a misshapen head). In this condition, a child will generally have a flattened spot on one side of their head as the soft bones conform to the flat surface of the bed, car seat, etc., while the weight of the head causes the skull to extend unevenly on the side on which the child is not resting. Over time, this can result in a pronounced protrusion on one side of the child's head accompanied by a relatively large flat spot on the other side of the head. While it is common for most children to have some asymmetry about their heads, the asymmetry caused by the protrusion and flattened portion can become quite pronounced and leave a clearly asymmetrical head. Once a deformation has occurred, the child is more likely to lay with the flattened portion of the skull on the mattress, etc., as it takes effort on the part of the child to rotate the head to position the protrusion at the bottom.
As a child reaches about 6 months old, the bones in the head begin to harden and permanently attach along the sutures and fontanelles. Thus, the shape of the head after 6 months of age remains more constant. If a child has deformational plagiocephaly at that time, the bones in the head will begin to harden in that shape. Thereafter to correct shape of the head usually requires the wearing of a helmet which applies pressure to the cranial bones as the child continues to grow, thereby ultimately achieving a more desired shape.
For young infants, however, deformational plagiocephaly is relatively easy to treat in accordance with the present invention when it is caused by positioning of the head. (Other forms of cranial deformation, may also be treatable by this method. However, for ease of convenience, the discussion will focus only on deformational plagiocephaly caused by sleep/rest position.)
Because the bones are still relatively malleable, selective control of the positioning of the head while a child sleeps provides for a natural, pain-free correction to the cranial deformation and provides a more symmetrical head shape. Thus, there is a need for a simple and inexpensive approach to correct deformational plagiocephaly. Additionally, it is desirable to provide such an approach which will cause little if any discomfort to the child and which does not require the wearing of the helmet and the like.